TINTED LIP SUNSCREEN- titanium dioxide, zinc oxide stick

Tinted Lip Sunscreen by

Drug Labeling and Warnings

Tinted Lip Sunscreen by is a Otc medication manufactured, distributed, or labeled by Scottsdale Skin Boutique and Dermatology Pllc, Fragrance Manufacturing Inc, Custom Analytics LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

PURPOSE

INDICATIONS & USAGE

WARNINGS

KEEP OUT OF REACH OF CHILDREN

DOSAGE & ADMINISTRATION

INACTIVE INGREDIENT

OTHER SAFETY INFORMATION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TINTED LIP SUNSCREEN 
titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85331-212
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	38 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ZINGIBER OFFICINALE (GINGER) ROOT OIL (UNII: SAS9Z1SVUK)
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX (UNII: 42DG15CHXV)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CERESIN (UNII: Q1LS2UJO3A)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ALUMINA (UNII: LMI26O6933)
PEG-8 (UNII: B697894SGQ)
TOCOPHEROL (UNII: R0ZB2556P8)
CITRIC ACID (UNII: 2968PHW8QP)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
HEXYLDECANOL (UNII: 151Z7P1317)
CI 77492 (UNII: EX438O2MRT)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
FLAVOR SPICE MINT N&A110589 (UNII: KG6KU384XW)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
DIPROPYLENE GLYCOL CAPRATE/CAPRYLATE DIESTER (UNII: R6G12EY23X)
CI 77499 (UNII: XM0M87F357)
HEXYLDECYL LAURATE (UNII: 0V595C1P6M)
CI 77491 (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85331-212-45	4.5 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/20/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/20/2022

Labeler - Scottsdale Skin Boutique and Dermatology Pllc (098226198)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc		793406000	manufacture(85331-212)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85331-212)